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Evaluación en servicio del cribado neonatal de la atrofia muscular espinal y el déficit inmunitario combinado grave (SMA y SCID)

Original In Service Evaluation into Newborn Screening for Spinal Muscular Atrophy and Severe Combined Immunodeficiency (SMA and SCID)

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El Department of Health and Social Care (DHSC) de Inglaterra busca manifestaciones de interés de organizaciones de los sectores voluntario, comunitario, social y privado para actuar como colaboradores o donantes estratégicos. No se trata de una contratación pública conforme al Procurement Act 2023; el DHSC busca contribuciones financieras para la puesta en marcha y el funcionamiento de seis centros adicionales de cribado neonatal durante dos años, con el primero previsto para operar en el tercer trimestre de 2027. El objetivo es ampliar la evaluación del cribado de la atrofia muscular espinal y el déficit inmunitario combinado grave para ofrecerlo a todos los bebés de Inglaterra. Los interesados deben completar el cuestionario en línea antes del 7 de agosto a las 23:59.

Descripción

1. INTRODUCTION 1.1. This general information notice is published to provide information about how the Department of Health and Social Care (DHSC) will be engaging with interested parties to find one or more strategic collaborator/donor. 1.2. DHSC is seeking expressions of interest from organisations in the voluntary, community, social enterprise (VCSE) and private sectors to collaborate in support of both the capital and revenue commitments to enable the extension at pace of the existing In Service Evaluation (ISE) into newborn Spinal Muscular Atrophy (SMA) screening in England, which will also include evaluating screening for Severe Combined Immunodeficiency (SCID). 1.3. The focus of this collaboration is the financial contribution required for the set up and running of an additional 6 newborn screening centres over a two year period (with the first of the additional centres looking to be operational by Q3 of 2027) 1.4. This is not a public procurement or sponsorship opportunity and will not result in the award of a “public contract” (within the meaning of the Procurement Act 2023). DHSC is specifically looking for financial contributions and wishes to hear from interested parties who can help us to: • Extend the screening and laboratory testing process to enable all babies in England to receive the offer of screening. • Help with the early identification of SMA[GD1.1][RX1.2][DG1.3] in newborns by extending the evaluation of SMA / SCID screening to an additional 6 labs. Engagement process and deadline 1.5. Full details of the requirement can be found within section 3 of this document. Those wishing to participate in the engagement process should register their interest by completing and submitting the questionnaire at the following link: https://forms.office.com/e/2FwiSsY8ib 1.6. The closing date for responses is on: 7th August at 23.59 pm. We reserve the right not to accept responses after this time. 1.7. We will be using a fair and non-discriminatory evaluation method to select interested parties to enter into discussions regarding a potential collaboration/donation agreement following the close of the early market engagement process. 1.8. DHSC will carry out due diligence relating to your organisation’s financial position, track record and other information it reasonably deems necessary or appropriate to satisfy itself as to the accuracy and adequacy of the responses received. This may involve the use of a range of tools and sources including, but not limited to, data analytics and artificial intelligence (AI). 1.9. DHSC intends to select organisations to collaborate with, but it reserves its right to select fewer organisations and/or not form a collaboration/donation agreement. 1.10. The questionnaire contains 4 questions for interested parties to answer. Each question refers to a key aspect of the requirements set out in Appendix 1. Each question will be scored on a scale of 0-4 using the scoring criteria set out below: Score Criteria for awarding score 0 Failure to understand requirements and provides no confidence that the requirement will be met. 1 The response meets some elements of the requirement but falls short in many significant areas. There are strong reservations because the response shows: Some misunderstandings of the requirements and insufficient supporting information is provided. It provides low confidence that the requirements will be met. 2 The response broadly meets what is expected for the requirements, but there are some areas of concern. The response shows: A basic understanding of the requirements and a minimum level of supporting information provided. It provides reasonable confidence that the requirements will be met. 3 The response meets the requirements in all material respects, with no or few areas of concern. The response shows: A good understanding of the requirements and a good level of supporting information provided. It provides good degree confidence that the requirements will be met. 4 The response exceeds many aspects of the requirements. There are no areas of concern. The response shows: A very good understanding of the requirements and very good level of supporting information provided. It provides a high degree of confidence that the requirements will be met. 2. BACKGROUND Spinal Muscular Atrophy (SMA) in newborns is a severe genetic condition that affects the motor nerves in the spinal cord. This nerve damage leads to progressive muscle weakness, severely impacting a baby’s ability to move, swallow, and breathe. It is a leading genetic cause of infant mortality. SMA is caused by a missing or faulty gene called SMN1. For a baby to be born with SMA, both biological parents must be carriers of this mutated gene and pass it on to their child. Carriers typically show no symptoms themselves. In many countries, SMA is now included in routine newborn screening programs (often part of the newborn blood spot or "heel prick" test) to allow for early diagnosis before symptoms even begin. Diagnostic confirmation involves a simple genetic blood test. Severe combined immunodeficiency (SCID) is the name given to a group of rare, inherited disorders that cause major abnormalities of the immune system. They form part of a larger group of conditions known as primary immunodeficiencies. The immune system abnormalities in SCID lead to greatly increased risks of infection and other complications that are life-threatening. Affected infants become unwell within the first few months of life, and before modern medication and treatments were available, most affected babies did not survive beyond their first year. At present, DHSC via NHS England are currently funding the implementation of “in-service evaluation” SMA screening in seven of England's thirteen newborn blood spot screening laboratories, (screening 410,000 babies per year). All of these seven laboratories possess the infrastructure, workforce expertise and operational capability required. These laboratories are also currently delivering Severe Combined Immunodeficiency (SCID) screening using the same testing platform and processes. To move at pace and lift screening capacity to all 13 screening laboratories which would provide coverage to the whole of England (additional 185,000 babies per year) further financial support is required.

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Fuente: Find a Tender Service (UK Cabinet Office / Crown Commercial Service)

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